FDA.reportPublic FDA data

Sacroiliac Joint Fusion System

Primary DI
M719GSI2000950
Brand
Sacroiliac Joint Fusion System
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GSI200-095
Device description
9.5mm SI Drill
Published
2019-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191748000Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine2019-09-26OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GSI2000950PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter9.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5123817070info@genesysspine.com

Regulatory Flags#

DUNS number
017921066
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M179GSI265STS0Sacroiliac Joint Fusion1GSI265-ST-S2026-07-14
M719G120140SIros-X12026-07-14
M719GGSI265XLGS0Sacroiliac Joint Fusion1GSI265-XLG-S2026-07-14
M719GL2290TiLock1GL2292026-07-14
M719GLL100QC03DP Lumbar Interbody System1GLL100-QC2026-07-14
M719GLL101QC03DP Lumbar Interbody System1GLL101-QC2026-07-14
M719GLL106QC03DP Lumbar Interbody System1GLL106-QC2026-07-14
M719GLL107QC03DP Lumbar Interbody System1GLL107-QC2026-07-14
M719GCL05L0Apache1GCL-05-L2015-08-31
M719GCL06L0Apache1GCL-06-L2015-08-31
M719GCL06S0Apache1GCL-06-S2015-08-31
M719GCL07L0Apache1GCL-07-L2015-08-31
M719GCL07S0Apache1GCL-07-S2015-08-31
M719GCL08L0Apache1GCL-08-L2015-08-31
M719GCL08S0Apache1GCL-08-S2015-08-31
M719GCL09L0Apache1GCL-09-L2015-08-31
M719GCL09S0Apache1GCL-09-S2015-08-31
M719GCL10L0Apache1GCL-10-L2015-08-31
M719GCL10S0Apache1GCL-10-S2015-08-31
M719GCL11L0Apache1GCL-11-L2015-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M179GSI265STS0Sacroiliac Joint FusionGenesys Orthopedics Systems LLCOUR2026-07-14
M719G120140SIros-XGenesys Orthopedics Systems LLCOUR2026-07-14
M719GGSI265XLGS0Sacroiliac Joint FusionGenesys Orthopedics Systems LLCOUR2026-07-14
00889929072738NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-05-01
07613327075830ASNISStryker GmbHOUR2015-11-11
07613327076189ASNISStryker GmbHOUR2015-11-11
07613327076301ASNISStryker GmbHOUR2015-11-11
07613327076554ASNISStryker GmbHOUR2015-11-11
07613327076721ASNISStryker GmbHOUR2015-11-11
07613327076929ASNISStryker GmbHOUR2015-11-11
07613327077049ASNISStryker GmbHOUR2015-11-11
07613327077308ASNISStryker GmbHOUR2015-11-11
07613327077315ASNISStryker GmbHOUR2015-11-11
07613327077346ASNISStryker GmbHOUR2015-11-11
07613327077391ASNISStryker GmbHOUR2015-11-11
07613327077414ASNISStryker GmbHOUR2015-11-11
07613327077483ASNISStryker GmbHOUR2015-11-11
07613327077513ASNISStryker GmbHOUR2015-11-11
07613327077544ASNISStryker GmbHOUR2015-11-11
07613327077582ASNISStryker GmbHOUR2015-11-11
07613327077605ASNISStryker GmbHOUR2015-11-11
07613327077612ASNISStryker GmbHOUR2015-11-11
07613327077643ASNISStryker GmbHOUR2015-11-11
07613327077674ASNISStryker GmbHOUR2015-11-11
07613327077704ASNISStryker GmbHOUR2015-11-11
07613154158980NAStryker GmbHOUR2015-09-24
07613252232674ASNISStryker GmbHOUR2015-09-24
07613252232681ASNISStryker GmbHOUR2015-09-24
07613252232698ASNISStryker GmbHOUR2015-09-24
07613252232704ASNISStryker GmbHOUR2015-09-24